Clarius Ultrasound Scanner 99-02-00009; 50-02-00003

GUDID 07540205000090

Clarius brand C3 Premium scanner

Clarius Mobile Health Corp

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 07540205000090
• NIH Device Record Key: 96bc54b3-51b5-461d-b6dd-8cd44606ecde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarius Ultrasound Scanner
• Version Model Number: C3 Premium Scanner
• Catalog Number: 99-02-00009; 50-02-00003
• Company DUNS: 202522751
• Company Name: Clarius Mobile Health Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540205000038 [Primary]
GS1	07540205000090 [Direct Marking]
GS1	07540205000199 [Primary]
GS1	07540205000298 [Primary]
GS1	07540205000595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163138
• Premarket Notification: K172385

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic
• IYN: System, Imaging, Pulsed Doppler, Ultrasonic
• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-21
• Device Publish Date: 2017-09-28

On-Brand Devices [Clarius Ultrasound Scanner]

• 07540205000847: Multi-port lithium ion battery charger
• 07540205000861: Mobile cart with multi-port battery charger
• 07540205000724: Clarius Fan
• 07540205000120: Clarius brand L7 Premium scanner
• 07540205000090: Clarius brand C3 Premium scanner
• 07540205000564: Clarius brand L7
• 07540205000540: Clarius brand C3-45 scanner
• 07540205000533: Clarius brand Charger
• 07540205000403: App - Android
• 07540205000397: App - iOS
• 07540205000182: Dock Station
• 07540205000335: Battery - ARTHREX
• 07540205000083: C3-60 Premium
• 07540205000175: ARTHREX Charger
• 07540205000168: Battery
• 07540205001158: Clarius fan
• 07540205000946: High-density transducer type – endocavity array (Clarius Scanner EC7 HD)
• 07540205000915: Clarius charger
• 07540205000908: Clarius Battery HD
• 07540205000977: High-density veterinary transducer type – phased array (Clarius Scanner PA HD)
• 07540205000960: High-density transducer type – high-frequency linear array (Clarius Scanner L15 HD)
• 07540205000953: High-density transducer type – linear array (Clarius Scanner L7 HD)
• 07540205000939: High-density transducer type – micro-curvilinear array (Clarius Scanner C7 HD)
• 07540205000991: High-density transducer type – curvilinear array (Clarius Scanner C3 HD)
• 07540205000984: High-density transducer type - high-frequency linear array (Clarius Scanner L20 HD)
• 07540205001042: The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for charging H
• 07540205001370: Accessory - Fan for Clarius Ultrasound Scanner
• 07540205001363: Accessory - Charger for Clarius Ultrasound Scanner
• 07540205001325: Portable Ultrasound Scanner
• 07540205001318: Portable Ultrasound Scanner
• 07540205001301: Portable Ultrasound Scanner
• 07540205001295: Portable Ultrasound Scanner
• 07540205001288: Portable Ultrasound Scanner.
• 07540205001271: Portable Ultrasound Scanner
• 07540205001189: Portable Ultrasound Scanner
• 07540205001356: Portable Ultrasound Scanner